Infant Care and Infant Health: Clinical Trials

The NICHD conducts and supports a variety of clinical research projects related to infant care and infant health. Select a link below to learn more about these projects.

Featured NICHD Clinical Trials on Infant Care and Infant Health

  • Global Network Implementation of Helping Babies Breathe (HBB)
  • HBB is a training program designed to resuscitate neonates regardless of where they were born. HBB was developed by the American Academy of Pediatrics, the NICHD's Global Network for Women’s and Children’s Health (GN), the Laerdal Foundation, and their global partners. The HBB program was developed based upon the experience and results of an earlier Neonatal Resuscitation Program and the GN’s FIRST BREATH randomized control trial. The study will examine the effects of training birth attendants in the HBB and Essential Newborn Care curricula upon perinatal mortality (fresh stillbirths and early neonatal deaths), among births of ≥1500g. The training will take place in three GN sitesone in Kenya, and two in India.
  • Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
    There is strong evidence that maternal breast milk feedings in infancy confer multiple health benefits in the extremely preterm population (ELBW <1000 g). Studies suggest an IQ advantage of up to 8 points conferred by maternal milk feeding in this population. Rates of sepsis and necrotizing enterocolitis are also lower in human-milk–fed ELBW infants, and they experience shorter hospital stays and fewer re-hospitalizations in the first year after birth. When mothers choose not to or are unable to provide milk, preterm formula is usually used. Pasteurized donor human milk is available in some NICUs in the United States as an alternative to preterm formula. Donor milk has not been well studied with regard to its safety and efficacy. The proposed study will be the first U.S. multicenter randomized trial of the health and developmental effects of donor milk as compared to preterm formula in ELBW infants receiving little or no maternal milk.
  • Generic Database of Very Low Birth Weight Infants (GDB)
    The GDB is a registry of very low-birthweight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, including the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is “generic”). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcomes, and to develop future NRN trials.
  • Event-Related Potentials in Infants and Adults
    This study will explore the development of visual perception and the brain activity that underlies it. It will examine electrical activity in the brain while people are processing characteristics of the visual environment, and it will look at how that processing might change with development.
  • A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
    CMV is a common virus that usually causes symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Pregnant women who have not been infected with CMV in the past and become infected during pregnancy may find that their babies are infected with CMV. Infected infants may develop permanent disabilities, including hearing loss, and a small portion will die from the infection. Currently it is not routine practice to screen pregnant women for CMV infection. The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies will reduce the number of babies infected with the virus.
  • National Children's Health Study
    The National Children’s Health Study is an observational longitudinal study that will enroll and follow a nationally representative sample of approximately 100,000 U.S.-born children from before birth through their 21st birthday.
  • Measuring and Reducing Excessive Infant Crying
    Excessive infant crying is likely to increase the risk of child abuse. Researchers at the University of Texas Health Science Center at Houston will systematically identify 170 term infants with this problem and conduct assessments in the home at 6 to 8 weeks of age to test the hypothesis that the intervention reduces mean infant hours of nighttime crying, increases maternal soothing behaviors, and improves parental anxiety and depression.
  • Promoting Optimal Parenting (Bright Start)
    The purpose of this study is to determine if providing parenting education materials delivered in different ways during the first 30 months after a child's birth will increase child-parent attachment and promote mother-child interaction; if certain types of strategies improve cognitive, language, and emotional development in infants and toddlers; and if Bright Start’s way of delivering these materials is cost-effective.
  • Healthy Infant Development Project
    This project will determine if providing micronutrient supplements to mothers during pregnancy and infants in the first 9 months after birth fosters healthy behavior and development in babies.

NICHD Clinical Trials Search Results

Information on current NIH-sponsored clinical trials on infant care and infant health can be obtained by consulting the link below or by calling 1-800-411-1222.


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